FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K Number: K251869
·
Decision Sep 15, 2025
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
3
Review Days
89
Basic Information
- Device Name
- Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
- K Number
- K251869
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Premium Plus (Dongguan) Limited
- Date Received
- June 18, 2025
- Decision Date
- September 15, 2025
- Product Code
- EGS
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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